Alta Sciences

MARCH 8, 2024

billion by 2029. Thousands of HPAPIs are currently in development that promise lower dose requirements, enhanced efficacy, improved patient compliance, and fewer side effects. So much so that the HPAPI market is estimated to reach USD 31.5

Compliance 52

Compliance Engineering Regulations Drug Development 52

Policy Prescription

MARCH 26, 2021

CBO looked at what would happen to the drug price market if elements of the Lower Drug Prices Now Act of 2019 (H.R. 3 contained policies to negotiate drug prices for Medicare. The savings to the government would be about $345 billion between 2023-2029 because of lower prices. 3) were implemented.

Drugs 52

Drugs Government Vaccine Pharmaceuticals 52

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

It is extremely difficult, if not impossible, to do the long-term planning and substantial fundraising required for drug development without knowing whether such an important and valuable incentive will be there. We heard and felt the anxiety from many of our clients about the uncertainty this caused.

Disease 64

Disease FDA FDA Approval Government 64

Vial

MARCH 1, 2024

Leading Global CROs To advance new therapies, pharma, biotech, and medical device sponsors engage CROs to help navigate the complex landscape of drug development and regulatory pathways and to manage clinical trials efficiently, ethically, and in compliance with good clinical practice ( GCP ) standards. billion by 2029.

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

Agency IQ

FEBRUARY 2, 2024

There are also continued questions about regulatory capacity and what the field will look like going forward, with implications for drug developers who rely on diagnostic products. A sea change for lab tests, the implications for drug developers and outstanding questions about endpoints In the U.S.,

FDA 40

FDA Laboratories Regulations Production 40